Med-tech powerhouse Johnson & Johnson (J&J) made a bold bid to bolster its interventional cardiology holdings with the news today that it is acquiring Shockwave Medical Inc. for approximately $13.1 billion including cash acquired. The $335 per share cash price represents a more than 5% premium to Shockwave’s (Nasdaq: SWAV) April 4 closing price and a more than 17% premium to the stock price prior to the Wall Street Journal report last week about the rumoured deal. J&J said it expects to finance the Shockwave deal through a combination of cash on hand and debt. The deal is expected to close by mid-2024, the companies said, pending approval from Shockwave’s shareholders, regulatory approvals, and other customary closing conditions. Shockwave posted product sales of $730.2 million in 2023. 

Paragonix breathes easier with Baroguard national launch

Paragonix Technologies Inc. expanded access to its U.S. FDA-cleared Baroguard system for the preservation and transportation of donor lungs following a successful limited release with a handful of top transplant centers. In addition to critical temperature control, the new system provides active airway management to keep lungs in the best condition possible.

US FDA, Renovo at loggerheads over added sterilization inventory

Some warning letters issued by the U.S. FDA are fairly simple matters, but that statement does not appear to apply to the Oct. 13, 2023, warning letter to Renovo Inc., of Bend, Ore. The warning letter provided a laundry list of sterilized reusable devices the agency said were not properly validated for sterilization, but the company rebutted these allegations in a vigorous defense of its reputation as a reprocessor.

Hollo Medical’s product to improve the lives of inhaler users

In what represents its first patenting, Halifax, Nova Scotia-based Hollo Medical Inc. seeks protection for its product that is designed for inhaler users who are frustrated with cumbersome valved holding chambers and desire something more compact and portable. Their flow rate control valve may be used as a device for delivering a medicated aerosol or mist to a user. The flow rate control valve may be directly connected to an inhaler (e.g., a pressurized metered dose inhaler) or connected to a spacer, such as an expandable bellows spacer, that is connected to an inhaler. The device may be used for the treatment or prevention of asthma, chronic obstructive pulmonary disease or any other treatment requiring dose delivery through the pulmonary system.

After the first approvals, where does amyloid go from here?

After decades of trying and dozens of failed trials, amyloid targeting has paid off. “We have the first disease-modifying agents on the market now,” Howard Fillit told BioWorld. But success does not mean slam dunk. Aduhelm (aducanumab, Biogen Inc.) was dogged by controversy throughout its brief tenure, and Biogen pulled the plug on it in early 2024. Leqembi (lecanemab, Biogen Inc.) has received full approval. Even when anti-amyloid approaches work, “their effect size is rather modest,” said Fillit, who is the co-founder and chief scientific officer of the Alzheimer’s Drug Discovery Foundation. And that effect is to slow down the rate of decline, not to stop or reverse it.

Also in the news

Biodesix, California X-ray Imaging Services, Emboline, Luscii Healthtech, Neurava, Neurocare, Omron Healthcare, Oraganox, Paragon 28, Prenosis, Quantalx, Rapidpulse, Revian, Sanara MedTech, Sebia, Shimadzu Medical Systems, Sophia Genetics, Spineology, Strand Life Sciences, Swat Medical, Vektor Medical